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Gensci-004 (PEG rhGH / Gensci 004 / PEG Somatropin)

✓ Approved

GeneScience Pharmaceuticals Co., Ltd. · GHR · Small Molecule

What is Gensci-004?

Gensci-004 is a small molecule developed by GeneScience Pharmaceuticals Co., Ltd.. It is approved for therapeutic indications via injectable (others) or subcutaneous injection.

Drug Profile

Brand NamesPEG rhGH, Gensci 004, PEG Somatropin
CompanyGeneScience Pharmaceuticals Co., Ltd.
Drug ClassSmall Molecule, Recombinant Proteins
Molecular TargetGHR,
RouteInjectable (Others), Subcutaneous Injection
StatusApproved
Sources: ClinicalTrials.gov, GeneScience Pharmaceuticals Co., Ltd.

Mechanism of Action

Molecular Targets

Gensci-004 acts on 2 molecular targets:

GHRgrowth hormone receptor (GHBP, GHIP)
(TERG_01127)
Want deeper analysis?Noah AI can explain complex mechanisms and compare to similar drugs.

Therapeutic Indications

Gensci-004 is developed for 1 unique indication across 1 therapeutic area.

Therapeutic AreaConditionPhase
Endocrine disordersGrowth hormone deficiency✓ Approved

Related Research Articles

PubMedEuropean heart journal2026-08-30

Adrenomedullin system dysregulation predicts cardiogenic shock and mortality in acute coronary syndromes.

Wang Yifan Y, Danchin Nicolas N, Simon Tabassome T, Zeller Marianne M et al.

Cardiogenic shock (CS) is the most dreadful complication of acute coronary syndromes (ACS). Endothelial dysfunction and vascular leakage are hallmarks of CS pathophysiology; however, biomarkers reflecting these early processes are lacking. The adrenomedullin (ADM) system-the inactive precursor glycine-extended ADM (ADM-Gly), the activating enzyme peptidylglycine α-amidating monooxygenase (PAM), and biologically active ADM (bio-ADM)-modulates vascular tone and permeability. This study investigated associations of ADM system components with CS and 1-year mortality risk after ACS. ADM-Gly, PAM, and bio-ADM were assessed in 4098 (Switzerland; SPUM-ACS) and 824 (France; FAST-MI) ACS patients without CS on admission. The primary endpoint was in-hospital CS; the secondary endpoint was 1-year mortality. Biomarker-outcome associations were analysed using multivariable-adjusted regression models, and the incremental predictive value beyond established risk scores was quantified. Higher ADM-Gly and bio-ADM, but not PAM, were associated with systemic inflammation and haemodynamic compromise. ADM-Gly and bio-ADM independently predicted CS risk in Switzerland (adjusted odds ratio [aOR] per log2 increase, 1.44, 95% confidence interval [CI] 1.22-1.71, P < .001 and aOR 1.37, 95% CI 1.10-1.70, P = .004) and France (adjusted risk ratio [RR] per log2 increase, 1.82, 95% CI 1.34-2.48, P < .001 and aRR 1.55, 95% CI 1.15-2.10, P = .004), and were associated with 1-year mortality risk (adjusted hazard ratio [aHR] per log2 increase, 1.33, 95% CI 1.09-1.61, P = .005 and aHR 1.46, 95% CI 1.15-1.86, P = .002). Addition of ADM-Gly and bio-ADM to the ORBI risk score improved its discrimination (Δ area under the receiver operating characteristic curve 0.02), reclassification (net reclassification improvement 0.229), and model fit (Δ Akaike information criterion -26.9), with consistent results in external validation. ADM-Gly and bio-ADM, but not PAM, independently predict in-hospital CS and 1-year mortality risk in initially stable patients with ACS and improve early risk stratification.

PMID 42668424
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PubMedJAMA2026-08-30

Anticoagulation Monotherapy vs Antiplatelet Monotherapy After Transcatheter Aortic Valve Implant: The ACASA-TAVI Randomized Clinical Trial.

Dodgson Christopher S CS, Herstad Jon J, Kløve Sophie F SF, Flygel Malin M et al.

Transcatheter aortic valve implant (TAVI) is increasingly being performed in younger and healthier patients with severe aortic valve stenosis. Antithrombotic therapy after TAVI is a key element of optimizing valve durability and clinical outcomes. To evaluate the safety and efficacy of a factor Xa inhibitor non-vitamin K antagonist oral anticoagulant (NOAC) monotherapy strategy vs an acetylsalicylic acid (ASA) monotherapy strategy after TAVI. Between December 2021 and June 2025, 360 participants between the ages of 65 and 80 years undergoing TAVI for severe aortic valve stenosis were enrolled in this prospective, randomized, open-label, blinded end point trial conducted at 3 Norwegian centers managing the majority of TAVI procedures nationally. The last patient completed follow-up on May 19, 2026. A total of 360 participants were randomly assigned (1:1) to receive 12 months of monotherapy with either NOAC (intervention) or ASA (control). A predefined co-primary end point strategy was chosen to address both efficacy and safety. The primary efficacy end point was TAVI valve leaflet thrombosis defined as the presence of hypoattenuated leaflet thickening (HALT) on blinded core laboratory 4-dimensional cardiac computed tomographic (CT) scan at 12 months. The primary safety end point was a composite of adjudicated Valve Academic Research Consortium 3 (VARC-3) bleeding events, thromboembolic events, and all-cause death at 12 months. Of the 360 participants randomized (mean age, 74.5 years [SD, 3.7]; 134 females [37%]), 336 completed the trial (168 in each group). The primary efficacy end point occurred in 27 participants (16.2%) allocated to the NOAC group and in 48 participants (28.6%) allocated to the ASA group (risk ratio, 0.55; 95% CI, 0.37 to 0.82, P = .004). The primary safety end point occurred in 13 participants (7.5%) in the NOAC group and in 19 participants (10.6%) in the ASA group (risk difference, -3.3%; 95% CI, -9.5% to 2.8%; P for noninferiority <.001). A strategy of NOAC monotherapy after TAVI reduced the incidence of HALT and was noninferior for bleeding, thromboembolic events, or death compared with acetylsalicylic acid monotherapy. These findings suggest that anticoagulation therapy can be beneficial after TAVI in selected patients. ClinicalTrials.gov Identifier: NCT05035277.

PMID 42669043
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PubMedThe American surgeon2026-08-29

Predictive Value of Preoperative Chest Computed Tomography-Measured Diaphragm Thickness Combined With Pulmonary Function for Postoperative Pulmonary Complications After Anatomic Lung Resection in Elderly Patients With Clinical Stage I Non-Small Cell Lung Cancer.

Wei Zhenqiang Z, Wei Dongshan D, Wu Kai K

BackgroundPostoperative pulmonary complications (PPCs) remain a major cause of adverse recovery after lung resection in elderly patients with early-stage non-small cell lung cancer (NSCLC). This study evaluated the predictive value of preoperative chest computed tomography (CT)-measured diaphragm thickness combined with pulmonary function for PPCs after anatomic lung resection.MethodsIn this single-center retrospective study, 248 patients aged 65 years or older with clinical stage I NSCLC who underwent lobectomy or segmentectomy between January 1, 2020 and December 31, 2025 were included. Preoperative CT-measured diaphragm thickness, pulmonary function indices, perioperative variables, and PPCs occurring within 30 days after surgery or during hospitalization were analyzed. Multivariable logistic regression and receiver operating characteristic analyses were performed.ResultsPPCs occurred in 54 of 248 patients (21.8%). Multivariable analysis showed that chronic obstructive pulmonary disease (odds ratio [OR], 2.29; 95% CI, 1.12-4.69; P = .023) and longer operative time (OR per 10-min increase, 1.13; 95% CI, 1.04-1.23; P = .004) were associated with increased PPC risk, whereas greater mean bilateral diaphragm thickness (OR per 0.1-mm increase, 0.88; 95% CI, 0.81-0.96; P = .004) and higher FEV1%pred (OR, 0.96; 95% CI, 0.93-0.99; P = .009) were protective. The area under the curve was 0.791 for mean bilateral diaphragm thickness, 0.752 for FEV1%pred, and 0.842 for the combined model; the bootstrap-corrected AUC was 0.829.ConclusionPreoperative CT-measured mean bilateral diaphragm thickness and FEV1%pred independently predicted PPCs after anatomic lung resection in elderly patients with clinical stage I NSCLC. Their combination provided improved predictive performance for preoperative risk stratification.

PMID 42667245
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PubMedVaccine2026-08-29

Maternal vaccination with RSVpreF and risk of hypertensive disorders of pregnancy: a systematic review and meta-analysis.

Alami Abdallah A, Lewis Meghan M, El-Chaâr Darine D, Walker Mark M et al.

A bivalent respiratory syncytial virus (RSV) prefusion F protein-based vaccine (RSVpreF) was approved in the United States in August 2023 for use during pregnancy to prevent infant RSV-associated lower respiratory tract disease. The pivotal phase 3 trial identified a numerical imbalance in hypertensive disorders of pregnancy (HDP) that did not reach statistical significance; postmarketing observational studies have since reported inconsistent findings. We conducted a systematic review and meta-analysis to assess this association. We searched MEDLINE, Embase, CENTRAL, Scopus, ClinicalTrials.gov, and WHO ICTRP from inception to Jan 26, 2026, for randomized controlled trials (RCTs) and observational studies comparing HDP outcomes in RSVpreF-vaccinated versus unvaccinated or placebo-receiving pregnant individuals. Unadjusted risk ratios (RRs) were pooled using a random-effects model; adjusted estimates from observational studies were pooled separately by inverse variance methods. This study is registered with PROSPERO (CRD420251026835). Nine studies were included (3 RCTs, 6 retrospective cohort studies; n = 148,267). RSVpreF vaccination was associated with a small but statistically significant increase in overall HDP risk (RR 1·08, 95% CI 1·02-1·13; p = 0·004; I2 = 44%), driven by the observational studies group (1·08, 1·02-1·14; I2 = 61%); RCTs showed a directionally consistent but non-significant RR (1·12, 0·87-1·43; I2 = 0%). The association was attributable to gestational hypertension, with no significant association for preeclampsia/eclampsia. Maternal RSVpreF vaccination was associated with a small increase in HDP attributable to gestational hypertension and driven primarily by observational studies, in which residual confounding remains possible. The benefits of infant RSV prevention remain substantial, and these findings support continued postmarketing surveillance and informed shared decision-making.

PMID 42667900
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PubMedChild abuse & neglect2026-08-28

Child sexual exploitation in a French child welfare cohort: Maltreatment histories, psychological and behavioural difficulties, and suicidal ideation.

Essadek Aziz A, Guenoun Tamara T, Mathieu Joris J, Lanctôt Nadine N et al.

Quantitative evidence on child sexual exploitation (CSE) in child welfare populations remains limited, particularly in France. This study examined CSE, associated maltreatment and psychological difficulties, and its indirect association with suicidal ideation. We conducted a retrospective cross-sectional study using case-file data for 1315 youth receiving child protection services in Essonne, France. Logistic regression models were adjusted for age, sex, age at entry into care, and school enrolment. Firth penalized logistic regression was used for restricted comparison, and exploratory mediation analyses used 1000 bootstrap simulations. CSE was identified in 62 youth (4.72%); 27.4% were boys. Youth with CSE were older, entered care later, and were more frequently not enrolled in school. Childhood sexual abuse showed the strongest adjusted association with CSE (aOR = 11.01, 95% CI [6.13-20.32], p < .001). Compared with youth who had experienced sexual abuse without CSE, those with CSE had higher odds of self-harm (Firth OR = 2.89, 95% CI [1.55-5.46]), aggression (Firth OR = 2.76, 95% CI [1.46-5.32]), alcohol use (Firth OR = 9.84, 95% CI [2.10-89.45]), and other substance use (Firth OR = 9.79, 95% CI [3.46-32.68]). In multivariable mediation analysis, CSE statistically accounted for 26.4% of the association between childhood sexual abuse and suicidal ideation (ACME = 0.026, 95% CI [0.007-0.044], p = .004). CSE identifies a subgroup with extensive adversity and substantial psychological and behavioural difficulties, supporting gender-inclusive, trauma-informed, and coordinated assessment and intervention.

PMID 42664666
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PubMedSleep advances : a journal of the Sleep Research Society2026-08-28

Associations of actigraphic sleep parameters with adipokines in older adults in the Baltimore longitudinal study of aging.

Wei Zhikui Z, Yue Yiwei Y, Rabinowitz Jill A JA, Kaizi-Lutu Marc M et al.

Sleep and adipokines are important regulators of cardiometabolic health, yet their relationship in older adults remains poorly understood. We examined cross-sectional and longitudinal associations of actigraphic sleep parameters with adipokine levels among older adults and explored sex and central obesity as potential moderators. We studied 350 participants aged ≥60 years (mean = 74.8 ± 8.3 years, 48.9% females, 19.4% black) from the Baltimore Longitudinal Study of Aging who completed 6.5 ± 1.1 nights of wrist actigraphy and provided fasting plasma for adipokine measurements. Predictors were total sleep time (TST), sleep onset latency, wake after sleep onset, sleep efficiency, and average wake bout length (AWBL); outcomes were adiponectin and leptin levels. At baseline, longer AWBL was associated with lower adiponectin (B = -2.02, 95% CI [-3.61, -0.42], p = .013) and leptin (B = -3.14, [-5.25, -1.03], p = .004) in fully adjusted models. Longer TST, modeled continuously, predicted a greater increase in adiponectin levels over time (B = 0.26, [0.081, 0.44], p = .007), and short TST (<6 h) was linked to subsequent decline in adiponectin (B = -0.90, [-1.72, -0.079], p = .038). Sex and central obesity moderated the baseline AWBL-adiponectin associations, which were significant in females (B = -3.92, [-6.25, -1.59], p = .001) and those with lower central obesity (B = -6.98, [-10.43, -3.53], p < .001). Longer sleep duration and shorter wake bouts are linked to more favorable adipokine profiles in older adults, especially in females and those with lower central obesity. Sleep may exert cardiometabolic effects through adipokines in older adults.

PMID 42662704
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